FDA Issues Draft Guidance for Industry, Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products

The draft guidance provides sponsors and other stakeholders with considerations when either designing a registry or proposing to use an exis

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS . FDA Issues Draft Guidance for Industry, Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products    Today, the U.S. Food and Drug Administration issued a draft guidance for industry titled Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products. The draft guidance provides sponsors and other stakeholders with considerations when either designing a registry or proposing to use an existing registry to support a regulatory decision about a drug's effectiveness or safety.   The draft guidance provides recommendations for a registry's fitness-for-use in regulatory decision-making, focusing on attributes of a registry that support the collection of relevant and reliable data. It also provides considerations when linking a registry to another data source for supplemental information, such as data from medical claims, electronic health records, digital health technologies, or another registry. Lastly, the guidance provides considerations for supporting the FDA's review of submissions that include registry data.  This draft guidance is part of a series of guidances that FDA has already published, or plans to publish, as part of the agency's RWE Program and in support of the 21st Century Cures Act and Prescription Drug User Fee Act.     For information on the draft guidance and how to comment, please see the Federal Register Notice.    Learn More The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research  provides guidance, education and updates for regulated industry. Subscribe to CDER SBIA Email Updates Register for Upcoming Training View 2021 Recordings on YouTube Follow on LinkedIn Follow on Twitter This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707.  SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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